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From: Smith, Michael (CBER)
Sent: Tuesday, July 27, 2021 10:01 AM
To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda
<[email protected]>; Devlin, Carmel M <[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected]>
Subject: STN 125742.0: IR RE assessment of vaccine effectiveness
Elisa,
The review team has the below Information Request for Pfizer and BioNTech Manufacturing GmbH.
1. Regarding the cumulative incidence rates, please calculate vaccine effectiveness with confidence intervals during the two intervals of interest separately from days 35 -91 (i.e., 8 weeks of observation after dose 2) and
from days 91 -224 (more prolonged follow up post vaccination series).
2. We also request assessment of vaccine effectiveness during a time period
that is entirely further out from vaccination (e.g., starting at 4 months post-
dose 2). We acknowledge though that at some point unblinding and placebo cross -over started, and there may have been differential loss
between the two groups f rom blinded follow -up that could introduce bias
and/or confound the analyses.
Please respond within one week from today.
Regards,
Mike
- Please confirm receipt of this e- mail and let us know if you have any
questions.
Mike Smith, Ph.D.
Captain, USPHS
Senior Regulatory Review Officer
Food and Drug Administration
FDA-CBER-2021-5683-1150192
Center for Biologics Evaluation & Research
Office of Vaccines Research & Review
Division of Vaccines and Related Products Applications
Tel: 301- 796-2640
[email protected]
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FDA-CBER-2021-5683-1150193